Implementing a randomised controlled trial through community pharmacies to support people living with severe and persistent mental illness: Lessons learnt during the COVID-19 pandemic.

Public health orders were introduced in many countries, including Australia, during the COVID-19 pandemic to reduce the spread of the virus. However, for many people this led to an exacerbation of mental health symptoms, particularly those living with severe or persistent mental illness (SPMI). Additionally, the conduct of clinical research was severely impacted during the pandemic, with many difficulties encountered in the conduct of clinical trials. This paper describes the COVID-related impacts experienced during the implementation of a randomised controlled trial (RCT) testing the effectiveness of a community pharmacist-led support service for people living with SPMI in Australia (the PharMIbridge RCT), and the strategies used to successfully implement the RCT. Australian public health orders led to interstate border closures, stay-at-home orders and work-from-home requirements, resulting in necessary changes to allow for the continuation of the RCT including; changes to trial regions, transferring some training materials online while delaying face-to-face (F2F) training components, delays in pharmacy and consumer recruitment, encouraging telehealth service delivery and extensions to timelines with existing funding. Having a solution-focussed and flexible approach, while still ensuring critical trial protocol elements were adhered to, such as providing opportunities for F2F skills-based training for pharmacists, as well as F2F site visits from researchers and mentors to support trial implementation, resulted in high pharmacy and consumer participant retention through to trial conclusion. Future planning for RCTs should consider possible pandemic-related risks and rapid responses from approval bodies to ensure researchers can be agile and adapt to ensure successful trial completion.

The impact of COVID-19 on clinical research at Australian and New Zealand universities: A qualitative study.

Background: The COVID-19 pandemic resulted in the implementation of social distancing measures, travel restrictions, and infection control measures that introduced a myriad of disruptions in the conduct of clinical research worldwide. As a result, many aspects of clinical research were variably impacted. Aim: To explore the impact of the first 18 months of the COVID-19 pandemic on clinical research across accredited nursing, pharmacy, and medicine program providers in Australian and New Zealand universities. Methods: Representatives from all program providers across Australian and New Zealand universities, with publicly available contact information, were invited to participate in this qualitative study, whereby semi-structured interviews were completed with participants who held senior research or leadership positions within their institution. Interviews were transcribed verbatim and inductively analysed using thematic content analysis. Findings: Interviews were conducted with 16 participants between August and October 2021. Two major themes were identified (Immediate Research Impact and Broader Research Impact) with six subthemes: Prioritisation, Continuation, and Dissemination of Research; Modifications to Research; Funding and Changes to Research Focus; Collaboration; Research Workforce; Context-specific Impacts. Discussion: The impact on clinical research in Australian and New Zealand universities included changes to data collection methods, a perceived decreased quality of research, changes to collaboration, neglect of basic disease research, and loss of the research workforce. Conclusion: This study highlights the impact of the COVID-19 pandemic on clinical research within the Australian and New Zealand university context. Implications of these impacts should be considered to ensure long-term sustainability of research and preparedness for future disruptions.

The "affected" pharmacist and the "business as usual" pharmacist: Exploring the experiences of pharmacists during COVID-19 through cluster analysis.

BACKGROUND: The global coronavirus disease 2019 (COVID-19) pandemic has necessitated considerable changes in the delivery of pharmacy services, with pharmacists experiencing increasing demands and a high rate of burnout. The ability to categorize pharmacists based on their burnout risk and associated factors could be used to tailor burnout interventions. OBJECTIVE: This study aimed to identify subgroups (profiles) of pharmacists and use these profiles to describe interventions tailored to improve pharmacist's well-being. METHODS: A survey was disseminated to pharmacists working in Australia during April and June 2020. The survey measured demographics, burnout, and psychosocial factors associated with working during COVID-19. A two-step cluster analysis was used to categorize pharmacists based on burnout and other variables. RESULTS: A total of 647 survey responses contained data that were used for analysis. Participants were mostly female (75.7%) and working full time (65.2%). The final cluster analysis yielded an acceptable two-cluster model describing 2 very different pharmacist experiences, using 10 variables. Cluster 2 (representing 53.1% of participants) describes the "affected" pharmacist, who has a high degree of burnout, works in community pharmacy, experiences incivility, is less likely to report sufficient precautionary measures in their workplace, and has had an increase in workload and overtime. In contrast, cluster 1 (representing 46.9% of participants) describes the profile of a "business as usual" hospital pharmacist with the opposite experiences. Interventions focused on the "affected" pharmacist such as financial support to employ specialized staff and equitable access to personal protective equipment should be available to community pharmacists, to reduce the risk to these frontline workers. CONCLUSION: The use of cluster analysis has identified 2 distinct profiles of pharmacists working during COVID-19. The "affected" pharmacist warrants targeted interventions to address the high burnout experienced in this group.

Guidance on the Conduct of Clinical Research within OECD Countries during the Early Stages of the COVID-19 Pandemic: A Systematic Review.

BACKGROUND: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. METHODS: Searches consisting of the terms "COVID-19", "clinical research", and "guidance", were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April-May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. RESULTS: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States' Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. CONCLUSIONS: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies.

A training programme for community pharmacists to support people living with severe and persistent mental illness: Intervention mapping in the context of a pandemic

Objective: The Bridging the Gap Between Physical and Mental Illness in Community Pharmacy (PharMIbridge) randomised controlled trial (RCT) aims to test the effectiveness of a pharmacist-led support service in improving medication adherence, and the physical and mental health of people living with severe and persistent mental illness compared to a standard medication review service. Method: Using the six-step intervention mapping (IM) framework, this paper describes the development and content of the PharMIbridge pharmacist training programme, an integral part of the RCT implementation, and continuous adaptations made to the process to keep pace with the evolving severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in Australia. A Training Working Group comprising health educators, practitioners, mental health consumers and researchers, refined the programme objectives and assisted with developing content and troubleshooting issues related to training delivery for pharmacists randomised to the RCT intervention arm. Results: A 2-day training programme was developed, which included Mental Health First Aid, simulated patient role-plays, and four pre-recorded modules using lectures, demonstration case vignettes, role-play activities and discussion. The programme, co-facilitated by project team members and mentors (pharmacist and consumer educators), aims to enhance pharmacists' mental health literacy, skills and confidence and empower them to engage with this vulnerable population using a strengths-based approach. Pre- and post-training questionnaires and interviews will be used to evaluate the impact of the PharMIbridge training programme. Conclusion: The systematic stepwise method provided by the IM framework highlights the solution-focused approach adopted by the project team and characteristics including adaptability and resilience which enabled training development and implementation across four Australian regions during the SARS-CoV-2 pandemic.

The “affected” pharmacist and the “business as usual” pharmacist: Exploring the experiences of pharmacists during COVID-19 through cluster analysis

Objectives The global COVID-19 pandemic has necessitated significant changes in the delivery of pharmacy services, with pharmacists experiencing increasing demands and a high rate of burnout. The ability to categorise pharmacists based on their burnout risk and associated factors, could be used to tailor burnout interventions. Therefore, this study aimed to identify sub-groups (profiles) of pharmacists and use these profiles to describe interventions tailored to improve pharmacist’s wellbeing. Methods A survey was disseminated to pharmacists working in Australia during April and June 2020. The survey measured demographics, burnout and psychosocial factors associated with working during COVID-19. A two-step cluster analysis was used to categorise pharmacists based on burnout and other variables. Results 647 survey responses contained data that were used for analysis. Participants were mostly female (75.7%) and working full-time (65.2%). The final cluster analysis yielded an acceptable 2-cluster model describing two very different pharmacist experiences, using 10 variables. Cluster two (representing 53.1% of participants) describes the “affected” pharmacist, who has a high degree of burnout, works in community pharmacy, experiences incivility, is less likely to report sufficient precautionary measures in their workplace, and has had an increase in workload and overtime. In contrast, cluster one (representing 46.9% of participants) describes the “business as usual” pharmacist profile of a hospital pharmacist with the opposite experiences.Interventions focused on the “affected” pharmacist such as financial support to employ specialised staff and equitable access to PPE should be available to community pharmacists, to reduce the risk to these frontline workers. Conclusions The use of cluster analysis has identified two distinct profiles of pharmacists working during COVID-19. The “affected” pharmacist warrants targeted interventions to address the high burnout experienced in this group.

The experiences of pharmacists during the global COVID-19 pandemic: A thematic analysis using the jobs demands-resources framework.

BACKGROUND: COVID-19 has necessitated a change to the way pharmacists are providing healthcare and has impacted the psychological wellbeing of these frontline healthcare workers. OBJECTIVE: To use the job demands-resources framework of burnout to describe the experiences of pharmacists working during COVID-19. METHODS: An online survey investigating burnout, psychosocial, and work-related factors affecting pharmacists during COVID-19 was distributed to a convenience sample of pharmacists practising in Australia during April and June 2020. The survey was distributed via social media and professional organisations. This study was a thematic analysis of the free-text question of the survey that asked participants to provide comment on anything they considered important. The job demands-resources framework of burnout was applied to the themes. RESULTS: Of 647 total survey responses, 215 (33.2%) participants responded to the free text question. Thematic analysis explored the increase in demands on pharmacists with a decreased availability of resources during COVID-19. Themes associated with high demands included an increased workload, provision of education and support to the community, taking on roles traditionally performed by others, managing medication and stock supply issues, and poor consumer behaviour. Themes representing resources, which were inadequate, included feeling supported by management and colleagues, feeling adequately trained, receiving clear and consistent communication, feeling valued and appreciated, personal safety, and recovery time. CONCLUSIONS: Pharmacists have experienced increased demands and reduced resources during COVID-19 which is associated with burnout. Knowledge of these demands and resources can inform interventions at an individual, workplace, and external level. Recommendations made in this paper are aimed at increasing resources available to pharmacists.

Mental Health First Aid training and assessment in Australian medical, nursing and pharmacy curricula: a national perspective using content analysis.

BACKGROUND: Suicide is among the leading causes of death among people aged 15 to 29 worldwide. Healthcare professionals interact with people at risk of suicide regularly, yet mental health and crisis first aid training is lacking in curricula. Mental Health First Aid (MHFA) training teaches crucial communication and crisis first aid skills and is increasingly recognised as integral to healthcare education. This study aimed to explore the extent of, as well as barriers and enablers to MHFA training delivery and assessment in Australian medical, nursing and pharmacy curricula. METHODS: All accredited Australian medical, nursing and pharmacy program providers were identified through Australian Health Practitioner Regulation Agency and National Boards websites and invited to participate in a semi-structured interview. A purpose-designed interview guide explored if and how MHFA training was delivered and assessed in curricula, as well as perceptions of and barriers and enablers to MHFA training. Interview recordings were transcribed verbatim, allowing for deductive content analysis to compare MHFA training provision across programs. RESULTS: Of 75 invited program providers, 36 (48%; 13 medical, 13 nursing and 10 pharmacy) participated, of which 15 representatives (42%; six medical, two nursing and six pharmacy) reported providing MHFA training to students. Differences in mandating training, year level of students completing training, type of training delivered and source of MHFA instructors were identified. Barriers to MHFA implementation included perceived adequacy of existing curricula, lack of funding and time, while facilitators included perceived benefit and availability of funding. CONCLUSION: MHFA training is provided to more than one third of medical, nursing and pharmacy students in Australia. Increased funding may facilitate the integration of MHFA as a minimum standard of mental health training for future healthcare professionals. Further research exploring the effectiveness of MHFA in improving behaviours and its impact on patient outcomes is warranted. TRIAL REGISTRATION: This study was approved by the University of Sydney Human Research Ethics Committee [Project number: 2020/087].

Burnout and the challenges facing pharmacists during COVID-19: results of a national survey.

Background COVID-19 has impacted the psychological wellbeing of healthcare workers and has forced pharmacists to adapt their services. Objective To measure burnout and describe the work and psychosocial factors affecting pharmacists during COVID-19, and to compare males and females. Setting An online survey was distributed to a convenience sample of pharmacists practicing in any setting in Australia during April and June 2020. Method The survey collected demographic data, burnout scores using the validated Maslach Burnout Inventory (MBI), psychosocial and work-related variables using questions adapted from previous surveys. It was tested for readability by a group of pharmacists and academic clinicians before distribution via social media and professional organisations. Main outcome measure Burnout was calculated using mean MBI scores, descriptive statistics were used to report work and psychosocial variables and Pearson's chi-square compared males and females. Results Overall, 647 responses were analysed. Most participants were female n = 487 (75.7%) with hospital n = 269 (42.2%) and community n = 253 (39.9%) pharmacists well represented. Mean (SD) for emotional exhaustion (possible range 0-54) and depersonalisation (possible range 0-30) were 28.5 (13.39) and 7.98 (5.64), which were higher (increased burnout) than reported pre-COVID-19. Personal accomplishment (range 0-48, lower scores associated with burnout) mean (SD) 36.58 (7.56), was similar to previously reported. Males reported higher depersonalisation indicating more withdrawal and cynicism. Working overtime, medication supply and patient incivility were reported to affect work. Conclusion Pharmacists are experiencing burnout, with work and psychosocial factors affecting them during COVID-19. Knowledge of this and that males experience more depersonalisation is valuable to inform advocacy and interventions to support pharmacists.

The burden of COVID-19 on pharmacists.

The unprecedented changes brought about by the global coronavirus disease 2019 (COVID-19) pandemic have had important impacts on society. The pandemic has provided an opportunity to highlight the crucial role pharmacists play in the provision of health care. The critical and unique role of pharmacists in pandemics and other disasters has been highlighted in the past (severe acute respiratory syndrome and Ebola outbreaks) and more recently with reports of the contributions of pharmacists during the global COVID-19 pandemic. Many reports have documented that health care professionals are experiencing significant psychological morbidity as a result of providing essential care and services during the global COVID-19 pandemic. In these reports, pharmacists are not well represented, and, therefore, it is essential to understand the impact of COVID-19 on pharmacists across multiple practice settings. This is particularly true as the experiences of pharmacists working through previous pandemics and disasters, and the associated psychological burden, are likely to offer insights and be useful in supporting the psychological well-being of pharmacists during the global COVID-19 pandemic. Research into the effect of the global COVID-19 pandemic on pharmacists should improve the understanding of the impact and the psychological morbidity associated with their role as frontline health care professionals.